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临床试验/CTRI/2025/09/094184
CTRI/2025/09/094184尚未招募不适用

Development And Validation Of Prediction Tool For Assessing Outcomes In Aneurysmal Subarachnoid Hemorrhage Patients Undergoing Clipping or Coiling

Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
230
试验地点
1
主要终点
To develop a prognostic model by identifying risk factors and other complications in different age groups with various comorbid conditions, leading to mortality during hospital stays and to identify the factors influencing the recovery outcomes such as Cognitive impairment and functional dependency in aSAH patients treated with different procedures.

研究概览

简要总结

Aneurysmal subarachnoid hemorrhage (aSAH) is a sudden onset life-threatening condition with a higher risk of morbidity and mortality. Predicting the patient outcomes remains challenging due to variability in radiological findings, clinical outcomes and postoperative complications. Current prognostic models for aSAH are mainly focused on mortality, length of stay, clinical risk factors, and surgical details. Most of the existing models were developed on retrospective data with a limited focus on recovery outcomes, excluding the aspects of neurological deficits, cognitive recovery and severity of functional dependency. The proposed prediction model will be developed based on a prospective cohort study and incorporates AI / ML-based algorithms to enhance accuracy by integrating various parameters of clinical, radiological, In-hospital complications, functional and cognitive outcomes in aSAH patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with Different Co-morbid conditions.

排除标准

  • Traumatic and Non-aneurysmal SAH conditions Previous history of Stroke.

结局指标

主要结局

To develop a prognostic model by identifying risk factors and other complications in different age groups with various comorbid conditions, leading to mortality during hospital stays and to identify the factors influencing the recovery outcomes such as Cognitive impairment and functional dependency in aSAH patients treated with different procedures.

时间窗: At hospital admission: Demographic details, comorbidities, clinical severity, risk factors. | During hospital stay: Development of complications, neurological status, interventions, and in-hospital mortality. | At discharge: Functional status, complications, immediate recovery outcomes. | At 1 month post-discharge: Cognitive impairment, functional dependency via standardized scales.

次要结局

  • To assess the correlation of clinical risk factors, treatment modalities (clipping vs. coiling), and in-hospital complications such as neurological and cardiopulmonary events with outcomes.(During hospital stay until discharge: Correlation of clinical risk factors, treatment modalities (clipping vs. coiling), and in-hospital complications (neurological and cardiopulmonary) with outcomes.)
  • To Identify the predictors and the occurrence of rehospitalization due to severe complications or neurological deterioration.(At 30 days post-discharge: Identification of predictors of poor recovery and occurrence of rehospitalization due to severe complications or neurological deterioration.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tripurari Sai Sreedhar

Manipal College of Pharmaceutical Sciences

研究点 (1)

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